EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events

NCT ID: NCT01069003

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-04-30

Brief Summary

EDUCATE is a prospective, multi-center study designed to collect real-world safety and clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet therapy (DAPT) drug regimen.

Detailed Description

To provide clinical information on rates of late and very late stent thrombosis after Endeavor Drug-eluting Stent (DES)placement in an all comers population with a broad range of bleeding and thrombosis risk. EDUCATE will further analyze the current practice of clinicians regarding temporary cessation of antiplatelet therapy and its association with clinical outcomes. In addition, patients included in this broad Endeavor registry will also be contributed to the DAPT native study population for analysis of 12 vs 30 months duration of dual antiplatelet therapy.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo Arm

Subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA). Eligible subjects are without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.

Group Type: PLACEBO_COMPARATOR

Placebo Arm

Intervention Type: DRUG

Placebo and ASA (75 mg - 325 mg)

Thienopyridine Therapy

Subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA). Eligible subjects are without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.

Group Type: ACTIVE_COMPARATOR

Thienopyridine Therapy

Intervention Type: DRUG

Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)

Surveillance Arm

Non randomized subjects followed through 24 months

Group Type: OTHER

Surveillance Arm

Intervention Type: DEVICE

Non randomized arm to understand clinical outcomes in a commercial setting

Interventions

Placebo Arm

Placebo and ASA (75 mg - 325 mg)

Intervention Type: DRUG

Thienopyridine Therapy

Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)

Intervention Type: DRUG

Surveillance Arm

Non randomized arm to understand clinical outcomes in a commercial setting

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient is older than 18 years.
• The patient or patient's legal representative has consented to participate and has authorized the collection and release of his medical information by signing the "Subject Informed Consent Form".
• Patients undergoing percutaneous intervention with Endeavor stent deployment (or has within 24 hours).
• The patient is willing and able to cooperate with study procedures and required follow up visits.

• Subject is "12 Month Clear".
• Subjects without known contraindication to dual antiplatelet therapy for at least 18 months after randomization.

Exclusion Criteria

• Index procedure stent placement with stent diameter < 2.5 mm or > 3.5 mm.
• Pregnant women.
• Current medical condition with a life expectancy of less than 3 years.
• The patient is currently participating in another investigational device or drug study that clinically interferes with the EDUCATE Study. The patient may only be enrolled in the EDUCATE Study once.
• Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use.
• Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
• Patients treated with any stent other than the Endeavor stent during the index procedure.

• Pregnant women.
• Subject switched thienopyridine type or dose within 6 months prior to randomization.
• Planned surgery necessitating discontinuation of antiplatelet therapy within the 18 months following randomization.
• Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.
• Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
• Current medical condition with a life expectancy of less than 3 years.
• Subjects on warfarin or similar anticoagulant therapy.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald Cutlip, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Harold Dauerman, MD

Role: PRINCIPAL_INVESTIGATOR

Fletcher Allen Hospital

Locations

AnMed Health Medical Center

Anderson, South Carolina, United States

Countries

United States

References

Cutlip DE, Kereiakes DJ, Mauri L, Stoler R, Dauerman HL; EDUCATE Investigators. Thrombotic complications associated with early and late nonadherence to dual antiplatelet therapy. JACC Cardiovasc Interv. 2015 Mar;8(3):404-410. doi: 10.1016/j.jcin.2014.10.017. Epub 2015 Feb 18.

Reference Type: DERIVED

PMID: 25703885 (View on PubMed)

Related Links

http://www.hcri.harvard.edu/

Harvard Clinical Research Institute

Other Identifiers

IP114

Identifier Type: -

Identifier Source: org_study_id